MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
Device Facts
| Record ID | K052805 |
|---|---|
| Device Name | MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 17, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal. Esaote's Model 7350 (MyLab50) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal. Esaote's Model 6150 (MyLab70) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatic Other: Urological, and Intraoperative Abdominal.
Device Story
MyLab30, 50, 70 are compact/mainframe ultrasound systems for diagnostic imaging. Inputs: ultrasound signals from phased, convex, linear array, and Doppler probes. Operation: B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). Output: real-time diagnostic images on LCD display. Used in clinical settings by healthcare professionals. Features include Compound Imaging, VPAN, and Tissue Velocity Mapping. Output assists clinicians in diagnostic assessment of various anatomical structures and fluid flow. Benefits: non-invasive diagnostic visualization of internal anatomy and hemodynamics.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on design similarity to predicate devices and performance testing of new transducers and indications.
Technological Characteristics
Ultrasound imaging systems (21 CFR 892.1550, 892.1560). Materials: standard medical-grade plastics/metals. Sensing: ultrasonic pulsed echo/Doppler transducers. Connectivity: LCD display, probe ports. Software: embedded firmware for image processing (B-Mode, M-Mode, Doppler, TEI, Compound Imaging). Quality System: ISO 9001:2000 and ISO 13485 certified.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal/Adult Cephalic, Small organ (Thyroid, Breast, Testicles), Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Urological, and Intraoperative Abdominal examinations.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- 7300 (MyLab30) (K040596)
- 7350 (MyLab50) (K050326)
- 6150 (MyLab70) (K051308)
- 6100 (MyLab90) (K051837)
Related Devices
- K060827 — MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 · Esaote, S.p.A. · May 19, 2006
- K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM · Esaote, S.p.A. · Jun 1, 2005
- K071996 — MYLAB30, MODEL 7300 · Esaote, S.p.A. · Aug 3, 2007
- K070903 — MYLAB40 · Esaote Europe B.V. · Jul 2, 2007
- K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
Submission Summary (Full Text)
{0}------------------------------------------------
510(k) Summary MyLab30. 50. 70 Systems Esaole. S.p.A.
K 052805
0C7 1 7 2005
### 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
#### Submitter Information
Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: (317) 849-1916 x103 Facsimile: (317) 577-9070
| Contact Person: | Carri Graham |
|-------------------------|----------------------------------------------------------------------------------------------------|
| Date: | September 29, 2005 |
| 807.92(a)(2) | |
| Trade Name: | MyLab30, 50, 70 Systems |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560 |
| Classification Number: | 90IYN; 90IYO |
#### 807.92(a)(3)
#### Predicate Device(s)
| K040596 | 7300 (MyLab30) | Esaote, S.p.A. |
|---------|----------------|----------------|
| K050326 | 7350 (MyLab50) | Esaote, S.p.A. |
| K051308 | 6150 (MyLab70) | Esaote, S.p.A. |
| K051837 | 6100 (MyLab90) | Esaote, S.p.A. |
{1}------------------------------------------------
510(k) Summary Mr Lab30, 50, 70 Systems Esaote. S.p.A.
#### 807.92 (a)(4)
#### Device Description
The 7300 (MyLab30), 7350 (MyLab50) and 6150 (MyLab70) system designs remain the same as those previously cleared by FDA via K040596, K050326, and K051308, respectively. They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.
The 7300 (MyLab30), 7350 (MyLab50) and 6150 (MyLab70) models are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
807.92(a)(5)
#### Intended Use(s)
Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal.
Esaote's Model 7350 (MyLab50) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal.
Esaote's Model 6150 (MyLab70) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatic Other: Urological, and Intraoperative Abdominal.
{2}------------------------------------------------
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## 9)(1) 2017-12-2018
# อมสร้างอิง เหตุการสตว์
| To be added via this 510(k) | MyLab90 (6100)<br>K051837<br>(Predicate) | MyLab30CV (7300)<br>K040596 | MyLab50 (7350)<br>K050326 | MyLab70 (6150)<br>K051308 |
|------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|-------------------------------------------|
| Doppler Probes<br>- 2.0 CW<br>- 5.0 CW | <span style="text-align:center;">✔</span> | YES | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> |
| IOE Probe<br>- IOE323 | <span style="text-align:center;">✔</span> | YES | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> |
| Biopsy Attachment<br>- ABS15 | <span style="text-align:center;">✔</span> | YES | YES | YES |
| VPAN | <span style="text-align:center;">✔</span> | YES | YES | YES |
| Compound Imaging | <span style="text-align:center;">✔</span> | YES | YES | YES |
| Intelligent Real Time<br>Processing | NO | NO | NO | YES |
| Intraoperative Abdominal<br>Indication for Use | <span style="text-align:center;">✔</span> | YES | YES | YES |
ବ əsindən filmlərin film bax və vəsilə ədəd vasitəsindən fəsiləsinin cinsinə aid bitk
YES
# Notice
It has come to our attention that certain individuals and entities are falsely claiming to be affiliated with or endorsed by Zeno Power Systems, Inc. These individuals and entities are misrepresenting themselves and their products or services as being associated with Zeno Power Systems, Inc., when in fact they are not.
Zeno Power Systems, Inc. is not responsible for any actions, representations, or omissions made by these individuals or entities. We urge you to exercise caution and due diligence when dealing with anyone claiming to be affiliated with Zeno Power Systems, Inc.
If you have any questions or concerns about the legitimacy of any individual or entity claiming to be affiliated with Zeno Power Systems, Inc., please contact us directly at [info@zenopower.com](mailto:info@zenopower.com).
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is composed of three stylized lines that resemble a human figure.
Public Health Service
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Esaote, S.p.A. % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250
Re: K052805
Trade Name: Model 7300 (MyLab30), Model 7350 (MyLab50), and Model 6150 (MyLab70) Ultrasound Imaging Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 29, 2005 Received: October 4, 2005
#### Dear Ms. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to I cactar Food, Drag, and sions of the Act. The general controls provisions of the Act include ane general only provents for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for r ms determination 7300 (MyLab30), Model 7350 (MyLab50), and Model 6150 (MyLab70) Ultrasound Imaging Systems, as described in your premarket notification:
{4}------------------------------------------------
#### Transducer Model Number
$$\frac{\text{IOE323}}{\underline{\text{CW}}}$$
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat FDA has made a determination that your device complies with other requirements of the Act that I Drinas Intact and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for an as a tion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Sceking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small
{5}------------------------------------------------
Page 3 – Ms. Graham
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Burgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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#### Diagnostic Ultrasound Indications for Use Form
#### Model 7300
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P [3] |
| Abdominal | | P | P | P | | P | P | | P [2] | P [3] |
| Intraoperative<br>(Abdominal) | | N | N | N | | N | N | | N [2] | N [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | P [2] | P [3] |
| Small Organ (specify) [1] | | P | P | P | | P | P | | P [2] | P [3] |
| Neonatal Cephalic | | P | P | P | | P | P | | P [2] | |
| Adult Cephalic | | P | P | P | | P | P | | P [2] | |
| Cardiac | | P | P | P | | P | P | | P [2] | P [3] |
| Transesophageal | | P | P | P | | P | P | | P [2] | |
| Transrectal | | P | P | P | | P | P | | P [2] | |
| Transvaginal | | P | P | P | | P | P | | P [2] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | P [2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | P [2] | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | P [2] | |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
(2) Applicable combined modes: B+M+PW+CW+CFM+PD
(3) Tissue Enhancement Imaging (TEI)
Compound Imaging VPAN Tissue Velocity Mapping (TVM) CMM CnTl
(PLEASE DO ROT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF
concurrence of CDRH, Office of Device Evaluation (t
Prescription Use (Per 21 CFR 801.109)
Nancy C. Roardon
Divisi n of Reproductive and logical Devic 510(k) Number
{7}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
#### Model 7350
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P [3] |
| Abdominal | | P | P | P | | P | P | | P [2] | P [3] |
| Intraoperative<br>(Abdominal) | | N | N | N | | N | N | | N [2] | N [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P [2] | P [3] |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | P [2] | P [3] |
| Neonatal Cephalic | | P | P | P | P | P | P | | P [2] | |
| Adult Cephalic | | P | P | P | P | P | P | | P [2] | P [3] |
| Cardiac | | P | P | P | P | P | P | | P [2] | P [3] |
| Transesophageal | | P | P | P | P | P | P | | P [2] | |
| Transrectal | | P | P | P | | P | P | | P [2] | |
| Transvaginal | | P | P | P | | P | P | | P [2] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P [2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P [2] | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P [2] | |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+CW+CFM+PD
- [3] Tissue Harmonic Imaging (TEI)
CMM
Tissue Velocity Mapping (TVM)
VPAN
Compound Imaging
- CnTI
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Burden
(Division Sign-Off)
Division of Reproductive, Abdi and Radiological Devices 510(k) Number
{8}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
#### Model 6150
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P [2] | P [3] |
| Abdominal | P | P | P | P | P | P | P | | P [2] | P [3] |
| Intraoperative<br>(Abdominal) | N | N | N | N | N | N | N | | N [2] | N [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P [2] | P [3] |
| Small Organ (specify) [1] | P | P | P | P | P | P | P | | P [2] | P [3] |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P [2] | P [3] |
| Adult Cephalic | P | P | P | P | P | P | P | | P [2] | P [3] |
| Cardiac | P | P | P | P | P | P | P | | P [2] | P [3] |
| Transesophageal | P | P | P | P | P | P | P | | P [2] | P [3] |
| Transrectal | P | P | P | P | P | P | P | | P [2] | P [3] |
| Transvaginal | P | P | P | P | P | P | P | | P [2] | P [3] |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P [2] | P [3] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | P [2] | P [3] |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | P [2] | P [3] |
| Other (Urological) | P | P | P | P | P | P | P | | P [2] | P [3] |
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+CW+CW+CFM+PD
- |3| Tissue Harmonic Imaging (TEI)
CMM VPAN Compound Imaging CriTI Tissue Velocity Mapping (TVM)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Off
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052805
{9}------------------------------------------------
#### 7300, 7350, and 6150 Systems
#### IOE323
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|-------|
| | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Adominal) | | N | N | N | | | N | N | | N (2) | N (3) |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | | N | N | | N [2] | N [3] |
| Small Organ (specify) [1] | | N | N | N | | | N | N | | N [2] | N [3] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | | N | N | | N [2] | N [3] |
| Laparoscopic | | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | N | N | N | | | N | N | | N [2] | N [3] |
| Muscolo-skeletal<br>Superficial | | N | N | N | | | N | N | | N [2] | N [3] |
| Other | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
[1] Small organs include Thyroid, Breast and Testicles.
[2] Applicable combined modes: B+M+PW+CFM+PD
- [3] TEI (Tissue Enhanced Imaging)
VPAN
Compound Imaging CnTI
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HELDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{10}------------------------------------------------
#### 7300 System
#### 2 CW
| | Mode of Operation | | | | | | | | | |
|-------------------------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | N | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic<br>Muscolo-skeletal | | | | | | | | | | |
| Conventional<br>Muscolo-skeletal<br>Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
#### (PLEASE DO NOT WRITE BELOW THIS LINE. COETIEUE OR ANOTHER PAGE IF NEEDED)
511(x) Number ________________________________________________________________________________________________________________________________________________________________
concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K052205
{11}------------------------------------------------
#### 7300 System
#### 5 CW
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | N | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
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concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broughton
(Division Sign-Off) Entision of Reproductive, Abdominal, and Rediological Devices 510(k) Number_
